Stereotactic Non-invasive Ablation of Ventricular Tachycardia

University Hospital Ostrava

Status: Withdrawn

Conditions: Ventricular Tachycardia

Treatments: Procedure: 4-D navigated stereotactic radio surgical ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03819504

NV19-02-00212 (Other Grant/Funding Number)

STAR-VT

Details and patient eligibility

About

STereotactic Ablative Radiosurgery of recurrent Ventricular Tachycardia in structural heart disease (STAR-VT).

Full description

The goal of this project is to evaluate feasibility and safety/toxicity of elimination of ventricular tachycardia (VT) associated with structural heart disease by noninvasive strategy, stereotactic radiosurgical ablation in an indication of bail-out procedure after failed catheter ablation. The arrhythmogenic substrate will be identified by imaging techniques and functionally by electroanatomic mapping and pacing. The recipients of stereotactic surgery will be patients after 2 unsuccessful catheter ablations for monomorphic VTs (one of the procedures will be performed in an expert center). The target volume for stereotactic radiosurgical ablation (single dose of 25 Gy) will be a critical region of the substrate defined by a combination of imaging and functional methods with an export of the merged image-electroanatomical map into the radiosurgery planning console. Primary endpoints will be a reduction of the burden of sustained VT, time to death or arrhythmic storm or appropriate therapy with implantable cardioverter-defibrillator (ICD) for isolated VT and/or time do development of radiation toxicity (both acute and late).

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with structural heart disease (ischemic and non-ischemic cardiomyopathy, previous surgery for congenital heart disease)
• Implanted ICD or CRT-D (cardiac resynchronization therapy defibrillator)
• Prior ≥1 catheter ablation procedure for monomorphic VT
• VT recurrence early (<12 months) after the last ablation with at least 2 episodes of recurrent VT, including 1 episode while on amiodarone (if not contraindicated)
• Age ≥30 years
• Signed an IRB-approved (Institutional Review Board) written informed consent

Exclusion criteria

• Acute myocardial infarction or recent percutaneous coronary intervention (PCI) or cardiac surgery (<3 months)
• Primary electrical disease (channelopathy)
• Reversible cause of VT (e.g. drug-induced, intoxications, etc)
• Pregnancy or breastfeeding
• Chronic heart failure New York Heart Association (NYHA) Class IV
• Serious comorbidities with presumed life expectancy less than one year
• Significant peripheral artery disease precluding retrograde aortic mapping
• History of chest radiotherapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

4-D navigated stereotactic radiosurgical ablation

Experimental group

Description:

Patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias will undergo 4-D navigated stereotactic radiosurgical ablation

Treatment:

Procedure: 4-D navigated stereotactic radio surgical ablation